Field of the Invention
[0001] This invention broadly relates to an element for an external ring fixator used for
stabilizing bone fractures in orthopedic surgery.
[0002] More particularly, the invention relates to a clamp element for external fixators
of the rod and ring type used for stabilizing bone fractures in orthopedic surgery;
such clamp element secures at least one of the bone fragment stretching wires and
the bone screws to one of the fixator rings.
[0003] As it is known in this technical field, external fixators are modular apparatuses,
comprising a plurality of component parts, which can be assembled with each other
into a variety of different configurations.
Prior Art
[0004] A typical example of this kind of fixator apparatuses is the Ilizarov system, wherein
bone fragment fixing rings can be assembled with each other by means of extendible
connecting tie rods or plates.
[0005] Such fixator apparatuses allow complex bone fractures to be recomposed, e.g. in the
case the bone end of a limb has been splinteredand one or more bone fragments happen
to be dislocated from said bone end.
[0006] In such cases, stretching wires are suitably used; such wires have an end threading
a hole drilled in the bone fragment, and bent over it in order to hold it in place.
The opposite end of the stretching wire is made fast to one of the rings and here
held.
[0007] In the Ilizarov system, the means used for securing the end of the stretching wire
to the rings consists of simple bolts, inserted in holes made in the rings, and their
associated nuts. Alternatively, special bolts having a hole drilled crossly to their
threaded shank may be used; the hole receives the end of the stretching wire which
is then clamped on the ring by means of a nut.
[0008] In some cases, for example when the bone fragment to recompose occurs at an intermediate
location of the limb, the end of the stretching wire must be fastened at an angle
to the plane containing the ring. In such cases, articulated clamp elements are used,
which usually comprise a first portion secured to the ring and a second portion inclined
to the plane of the ring and having clamping means of the stretching wire end.
[0009] Furthermore, different conditions of the bone fracture can require that a bone screw
be used having a threaded end engaged in the bone cortex, and having an opposite screw-handling
to be end secured to one of the rings. Here again, a respective different clamp element
must be provided.
[0010] Thus, a multiplicity of clamp elements -- differring from one another by their type,
function and assembling method -- must be made available, depending on whether the
stretching wire for bone fragments or a bone screw is to be secured to the ring. This
obviously involves higher manufacturing cost, since large volume production methods
cannot be applied.
[0011] In addition, the provision of a range of different clamp elements implies the disadvantage
for the orthopedic surgeon, who has always the duty to select the most suitable element
to complete the installation of the fixator device. This selection requirement works
against the necessity to have the fixator apparatus assembling and setting operations
completed within the shortest possible time.
[0012] The underlying technical problem of this invention is to contrive a clamp element,
particularly to be used in external fixator apparatuses of the rod and ring type,
with such structural and functional features as to allow its universal application
in a variety of assembling situations and conditions, and accordingly, its manufacture
in large volumes. The limitations and drawbacks of the solutions presently proposed
in the prior art would thus be overcome.
Summary of the Invention
[0013] The resolutive idea of this invention is to arrange for a clamp element to comprise
a pair of portions articulated with each other by a pivotal connection, each of such
portions being interchangeably usable to secure the clamp element either to one of
the fixator apparatus rings, or to a bone fragment stretching wire, or to a bone screw.
[0014] Based on this resolutive idea, this invention provides a clamp element as previously
indicated and defined in the characterizing portion of Claim 1.
[0015] The features and advantages of the clamp element according to the invention will
be apparent by reading the following description of a preferred embodiment thereof,
given by way of non-limitative example with reference to the accompanying drawings.
In the drawings:
Brief Description of the Drawings.
[0016] Figure 1 shows a perspective and schematic view of an external fixator apparatus
of the ring type for use in orthopedic surgery, which fixator apparatus incorporates
at least one clamp element according to the invention.
[0017] Figure 2 shows a perspective view of a clamp element formed according to the invention;
[0018] Figure 3 is a side view of the clamp element in Figure 2, shown in a first condition
of its use.
[0019] Figure 4 is a side view of the clamp element in Figure 2, shown in a second condition
of its use.
[0020] Figure 5 is a side view of the clamp element in Figure 2, shown in a third condition
of its use.
Detailed Description
[0021] Referring to the enclosed drawings, a clamp element for external fixator apparatuses
2, e.g. fixators of the rod and the ring type for stabilizing bone fractures in orthopedic
surgery, is at 1 inclusively and schematically shown.
[0022] Fixator apparatuses of the above type are usually applied to the outside of a limb
which has been injured by a bone fracture.
[0023] A rod and ring type of fixator apparatus 2 includes at least a pair of rings, e.g.
a proximal ring 6 and a distal ring 7, as well as tie rods 8, 9, 10 for connecting
the rings 6 and 7 to each other.
[0024] Advantageously, a clamp element 1 according to this invention can be connected to
either of said rings 6, 7 to secure at least one of the stretching wires 4 of a bone
fragment 3 and the bone screw 11.
[0025] More particularly, the clamp element 1 comprises a swivel joint 12 comprising a first
13 and a second 14 parts associated with each other around a common pivot axis x-x.
The parts 13, 14 are both formed with at least one hole 16 of a predetermined diameter
for securing the stretching wire 4 or the bone screw 11. Specifically, the first part
13 is formed with a hole 16a having a diameter of about 3mm for receiving the stretching
wire 4, and the second part 14 is formed with a hole 16b having a diameter of about
6mm for receiving the bone screw 11 and an optional takeup bush 11a.
[0026] In all cases, the diameter of the cross hole 16 in one of said parts is greater than
the diameter of the cross hole 16 in the other part of said parts.
[0027] Also, the parts 13, 14 both include a means 18 of clamping to a rod 8, 9, 10 or a
ring 6, 7 of said fixator apparatus.
[0028] Advantageously, the above-said clamping means 18 is also used for securing the stretching
wire 4 or the bone screw 11 to the portion of the swivel joint 12, unconnected to
the rod or to the ring.
[0029] Specifically, the clamping means 18 comprises a threaded seat 19 formed in one end
of each of said parts 13, 14 for receiving a clamp screw 20, preferably of the Allen
type.
[0030] Each said parts 13, 14 have an elongate cylindrical body, and the threaded seat 19
is formed in a free end 21 of the cylindrical body coaxially to the axis y-y of the
latter.
[0031] The swivel joint 12 is basically a toggle joint, and includes a means 22 of stopping
the pivotal angular rotation at a predetermined angular position around the common
pivot axis x-x of the parts 13, 14.
[0032] In particular, the stopping means 22 comprises a grubscrew 23 extending coaxially
to the pivot axis and adapted for manual operation using a suitable wrench.
[0033] It should be noted that the holes 16a and 16b in said first and second parts, 13
and 14, extend perpendicularly to the pivot axis x-x.
[0034] A threaded hole can be provided in the cylindrical body of each of the parts 13,
14, along a transverse direction to the seat 19 of said clamping means 18, for receiving
a grubscrew operated to prevent the clamp screw 20 from turning.
[0035] For the sake of completeness, it should be added that the clamp element of this invention
is made of a transparent material to X-radiation, such as a plastic matrix of polyetherketone.
Also, the cylindrical body of each of said parts 13, 14 is formed laterally with a
gripping impression 25 which essentially comprises a pair of parallel flats 24 provided
on opposite sides of the axis y-y of the cylindrical body.
[0036] These gripping impressions 25 lie close to the free end 21 of each part, and make
the handling of the clamp element easy, with or without the aid of a tool.
[0037] An explanation of how the clamp element of this invention can be used in an external
fixator apparatus of the rod and the ring type, schematically shown in Figure 3 will
be given next, preceded by a brief review of the construction of a ring type fixator
apparatus.
[0038] The rings 6 and 7 of the fixator 2 are superposed with a given distance apart, and
held in place by the tie rods 8, 9 and 10. A respective end of the fractured limb
is secured to each ring 6, 7, e.g. using suitable wires 4 for stretching bone fragments,
or the bone screw 11.
[0039] The tie rods 8, 9 and 10 substantially extend along parallel directions. Two, 8 and
10, of the three rods 8, 9 and 10 are usually placed in diametrically opposite positions,
while the third rod 9 is placed at 90°.
[0040] Each tie rod is threaded, and fastened to each ring by means of a nut and locknut.
[0041] The bone fragment stretching wire 4 is to be secured to one of the rings, 6 or 7,
the operation being easily carried out thanks to the clamp element 1. For this purpose,
the element 1 is fastened to the ring by the clamping screw 20, which screw engages
in the threaded seat 19 of one of the parts 13, 14 -- specifically part 14 formed
with the larger diameter hole 16b, as shown in Figure 4 -- of the swivel joint 12
through one of a number of holes provided in the ring 6 or 7.
[0042] The stretching wire 4 is threaded through the hole 16a of the part 13 of the swivel
joint 12 which is not fastened to the ring, and clamped therein by means of the screw
20 engaging in the corresponding threaded seat 19 at the free end of the part 13.
[0043] The angular setting of the swivel joint 12, that is the spatial lay of the part 13
relative to the part 14 fastened to the ring, is regulated by acting on the stop means
22 of the joint toggle.
[0044] In case a bone screw 11 is to be secured, instead of a stretching wire 4, it is enough
to mount the clamp element 1 on the ring 6 or 7 the other way around according to
what has been previously described, that is with the part 13 having the smaller diameter
hole fastened to the ring and the other part 14 clamped to the bone screw, as shown
in Figure 3.
[0045] The clamp connector 1 can also be used according to a further connecting arrangement.
In a preferred embodiment of the fixator device 2, at least one 10 of the tie rods
8, 9, or 10 comprises two rod sections, namely an upper rod section 10a and a lower
rod section 10b, both substantially having the same length.
[0046] Advantageously, the rod sections 10a, 10b can be swivel connected together by means
of the clamp element 1 of this invention. Each section can be engaged into a respective
threaded seat 19 of each corresponding joint parts 13, 14.
[0047] Thus, the swivel joint 12 will locate approximately in the middle of the tie rod
made up of the pair of sections, and enable adjustment of the relative inclination
angle of the sections to suit the mutual setting of the rings 6 and 7.
[0048] In essence, with the clamp element 1 of this invention constructed as described hereinabove,
the clamping of the stretching wire 4 or the bone screw 11 can be adjusted as desired
both in position on one of the rings 6, 7 and in inclination to the plane of the ring.
[0049] The main advantage of the clamp element according to this invention is represented
by its universal utility under different conditions of clamping either stretching
wires, or bone screws, and rod sections connecting the rings.
[0050] A further advantage is the ease of assembly and operation of the clamp element, which
can now be handily used by unskilled staff.
[0051] A further advantage is that the clamp element of this invention can be manufactured
in very large volumes at reasonable costs.
1. A clamp element for external fixator apparatuses (2) of the rod (8,9,10) and ring
(6,7) type used for stabilizing fractures in orthopedic surgery; such clamp connector
secures at least one of the bone fragment (3) stretching wires (4) and the bone screws
(11) to one of the fixator rings, characterized in that it comprises a swivel joint (12) consisting of a first part (13) and a second part
(14) associated with each other, each part (13,14) being formed with at least one
hole (16) of a predetermined diameter for clamping the stretching wire (4) or the
bone screw (11) therein, and with means (18) of clamping to a rod (8,9,10) or to a
ring (6,7) of said fixator apparatus.
2. An element, according to Claim 1, characterized in that the swivel joint (12) is a hinge, and that said first (13) and second (14) parts
are associated around a common axis (x-x) of said hinge.
3. An element according to Claim 1, characterized in that said clamping means (18) comprise a threaded seat (19) formed in one end of each
of said parts (13,14), and a nut or a screw adapted to engage said rod or said ring,
respectively.
4. An element according to Claim 3, characterized in that each of said parts (13,14) has an elongate cylinder body, and that said threaded
seat (19) is formed at a free end (21) of the cylindrical body along the axis (y-y)
of the latter.
5. An element according to Claim 2, characterized in that said threaded seat communicates to said hole (16).
6. An element according to Claim 2, characterized in that said swivel joint (12) comprises means (22) to stop the angular rotation of said
first and second parts around said common pivot axis (x-x).
7. An element according to Claim 1, characterized in that the holes (16) in said first (3) and second (14) parts extend perpendicularly to
the common pivot axis (x-x).
8. An element according to Claim 3, characterized in that it is formed with a hole extending transversely to said seat for engagement of a
grubscrew arranged to prevent said clamp screw from turning.
9. An element according to Claim 1, characterized in that the holes in said parts have different diameters.
10. An element according to Claim 4, characterized in that it is formed with a gripping impression (25) which is formed laterally on said body.
11. An element according to Claim 1, characterized in that it is made of a transparent material to X-radiation.